Fingolimod polymorphs and their processes
DC CAFCFirst Claim
Patent Images
1. Fingolimod hydrochloride crystalline Form-β
- characterized by X-ray powder diffraction pattern comprising characteristic 2θ
°
peaks selected from the XRPD peak set of 3.54, 7.07, 10.66, 15.35, 20.52, 21.43 and 25.10±
0.1 2θ
°
.
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Abstract
The present invention provides crystalline polymorphic forms of Fingolimod HCl (I) and processes for preparation thereof.
The application provides processes for preparation of crystalline polymorphic forms-α, β and μ substantially free from process related impurities. The crystalline polymorphic forms of Fingolimod HCl (I) obtained by the processes according to the present invention having an XRDP pattern as per FIGS. 1, 3 and 5, which are useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment or prevention of autoimmune related disorder including multiple sclerosis.
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6 Claims
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1. Fingolimod hydrochloride crystalline Form-β
- characterized by X-ray powder diffraction pattern comprising characteristic 2θ
°
peaks selected from the XRPD peak set of 3.54, 7.07, 10.66, 15.35, 20.52, 21.43 and 25.10±
0.1 2θ
°
. - View Dependent Claims (2)
- characterized by X-ray powder diffraction pattern comprising characteristic 2θ
-
3. Fingolimod hydrochloride crystalline Form-β
- characterized by X-ray powder diffraction pattern comprising characteristic 2θ
°
peaks selected from the XRPD peak set of 3.54, 7.07, 10.66, 15.35, 20.52, 21.43 and 25.10±
0.1 2θ
° and
DSC isotherm comprising the endothermic peaks ranging between 40 to 45°
C. (Peak-1), 65 to 70°
C. (Peak-2), 107 to 115°
C. (Peak-3) and/or 265 to 270°
C. (Peak-4). - View Dependent Claims (4)
- characterized by X-ray powder diffraction pattern comprising characteristic 2θ
-
5. A process for preparing Fingolimod hydrochloride crystalline Form-β
- comprising the steps of—
a. combining the Fingolimod hydrochloride with organic solvent selected from dimethylformamide, dimethylacetamide, tetrahydrofuran and 2-methoxyethanol; b. optionally heating upto about 40-50°
C. followed by cooling; andc. isolating the crystalline Form-β
using another co-solvent selected from acetone or acetonitrile by recrystallization. - View Dependent Claims (6)
- comprising the steps of—
Specification